February 11, 2016

Manchin Bill Demands FDA Address Opioid Epidemic

‘Changing the Culture of the FDA Act’ would amend FDA mission statement to hold agency responsible for addressing opioid epidemic

Washington, D.C. – U.S. Senator Joe Manchin (D-WV) today introduced the Changing the Culture of the FDA Act, a bill to expand the Food and Drug Administration’s (FDA) mission statement to require that the agency address the nation’s opioid epidemic. Senator Manchin believes that the FDA plays a critical role in the growing opioid epidemic since the agency oversees the approval of dangerously addictive drugs. However, to date, the agency has failed to consider the devastating public health impact of its repeated decisions to approve opioid medications.

Specifically, the Changing the Culture of the FDA Act would add the following language to the agency’s mission statement: “The FDA is also responsible for protecting the public health by strongly considering the danger of addiction and overdose death associated with prescription opioid medications when approving these medications and when regulating the manufacturing, marketing, and distribution of opioid medications.”

“The FDA must get serious about the dangers of prescription drugs, and this will not be accomplished without a significant change of culture at the agency,” Senator Manchin said. “The FDA’s number one priority must be the public’s health and well-being, nothing else. Yet, time and time again, the FDA has stood in the way of efforts to address the opioid abuse epidemic and improve public health. Although the FDA announced that it will be taking steps in the right direction to address these problems, it is not enough, and more needs to be done. This bill is an important step that must be taken to hold the FDA accountable for the impact its decisions are having on the American people.”

West Virginia has been hit the hardest in the nation by the opioid epidemic. Drug overdose deaths have soared by more than 700 percent between 1999 and 2013. Senator Manchin has made it his top priority to curb prescription drug abuse in any way possible, including changing the culture at the FDA.

To review a full timeline of Senator Manchin’s efforts in the Senate to combat prescription drug abuse, please click here.

To read a fact sheet on why this expansion is necessary, please click here.

To read the full text of the Changing the Culture of the FDA Act, please click here.